| Trial ID: | L4776 |
| Source ID: | NCT01561508
|
| Associated Drug: |
Gamma-Amino-Butyric Acid
|
| Title: |
Effect of GABA Supplementation in the Progression of Type 1 Diabetes in Children
|
| Acronym: |
GABA
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus
|
| Interventions: |
DRUG: gamma-amino-butyric acid|DIETARY_SUPPLEMENT: Xylitol
|
| Outcome Measures: |
Primary: change in stimulated c-peptide, We will measure c-peptide levels stimulated by a mixed meal tolerance test at baseline, six months and 12 months., over 1 year | Secondary: change in HbA1C, We will assess the change in hemoglobin A1C at baseline and every 3-4 months for a total duration of 1 year., over 1 year|change in total daily insulin dose per kilogram, We will assess the change in total daily insulin dose per kilogram of subject body weight at baseline and every 3-4 months for a total duration of 1 year., over 1 year
|
| Sponsor/Collaborators: |
Sponsor: University of Alabama at Birmingham
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-06
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2012-12-24
|
| Locations: |
University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01561508
|
